Tests LY3962681 in healthy volunteers and people with Parkinson's disease
Tests the drug LY3962681, given into the spinal fluid, in Parkinson's disease patients.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Key facts
- Where
- Oxford and Southampton, United KingdomSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Source: NCT06565195, who can take part
Where in United Kingdom
- John Radcliffe HospitalOxford, United KingdomNot yet recruiting
- Southampton General Hospital, NHS TrustSouthampton, United KingdomNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prevail Therapeutics
- Trial code
- NCT06565195EU 2024-513411-27-00
- Record updated
- 16 October 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease.Read full original descriptionShow less
A Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind (Sponsor-unblinded), Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease.
The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study.
During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid [aCSF]) administered intrathecally (into the spinal fluid). During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered intrathecally (into the spinal fluid), 12 to 24 weeks apart.
* The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 dosing days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks after Dose 2.
Inclusion: Participant is overtly healthy as determined by medical evaluation. Rescreening is allowed in this study; A Montreal Cognitive Assessment score greater than or equal to 24; MAD study only; Stable use of background medications at least 8 weeks prior to IP administration, including but not limited to those used for treatment of Parkinson's disease (including deep brain stimulation), and the investigator must expect that participant can tolerate a minimum of 6 months without dose adjustment; Participant has a diagnosis of Parkinson's disease per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria; Modified Hoehn and Yahr Stage 1 to 2.5 in the practically defined OFF state; A positive result on CSF alpha-synuclein Seed Amplification Assay. (A prior positive result [within 1 year of screening] accepted with sponsor approval if patient did not participate in another Parkinson's disease clinical trial during this period.) (US and Japan only); UPSIT score of 20 percentile or less, corrected for age and sex (EU and UK only); An abnormal DaT-SPECT consistent with parkinsonism. (History of an abnormal DaTSPECT with the report confirmed by study investigator will be accepted.); For participants not taking Parkinson's disease medications, not expected to initiate treatment within 6 months; Have a body weight within 40 kg (88 pounds) to 110 kg (242 pounds), inclusive, and body mass index within the range of 17 to 34 kg/m\^2, inclusive.
Exclusion: Current concomitant disease or serious or unstable illnesses, including central nervous system (SAD study only), cardiovascular, hepatic, renal, gastroenterology, respiratory, endocrinologic, neurologic (MAD study only: other than Parkinson's disease), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable safety risk to the participant; MAD study only: Treatment with continuous intestinal delivery Parkinson's disease medication (for example, Duodopa); MAD study only: Significant neurological disease affecting the central nervous system other than Parkinson's disease that may be a cause for the participant's clinical symptoms or may confound study objectives; Participant is generally frail or has any medical disorders that, in the opinion of the investigator, could interfere with study-related procedures (including safe performance of IT injection or LP), such as prohibitive spinal diseases, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, or increased intracranial pressure; MAD study only: Significant renal impairment (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m\^2); Other protocol-defined inclusion/exclusion criteria may apply; Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.